FMEA and Risk management according to ISO 14971

FMEA and Risk management according to ISO 14971

Risk management vs FMEA Risk management for medical devices is a comprehensive approach, including requirements for planning the development of a device, to the requirements for a device that is no longer on the market. Even though the standard in application of risk...
CE-mark a medical device

CE-mark a medical device

If you intend to place a device on the market in an EU or EFTA country, it must be CE marked by you as a manufacturer or part of a registered clinical investigation. CE stands for “Conformité Européenne”. The CE mark means that the product meets the essential...

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